biliary tract cancer not amedable for curative resection with progressive disease after first-line chematherapy with gemcitabine and cisplatin
Conditions
Interventions
Product Name: Irinotecan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Irinotecan
CAS Number: 136572-09-3
Other descriptive name: IRINOTECAN HYDROCHLORIDE
Concentrat
Sponsors
Goethe-Universität Frankfurt, PD Fabian Finkelmeier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent granted prior to initiation of any study specific screening procedures • Patients with histologically confirmed CCA or GB-CA not suitable for resection or metastatic • Progressive disease undergoing a systemic chemotherapy with a platin-derivate (Oxaliplatin, Cisplatin or Carboplatin) or progressive disease within 3 months after cessation of chemotherapy • Age >= 18 years • Performance status ECOG 0-2 • Normal organ and bone marrow function defined as: o Hematopoetic: absolute neutrophil count >1,500/mm3, platelet count >75,000/mm3, hemoglobin >9 g/dL o INR = 1.5 o Hepatic: AST or ALT =65 years) yes F.1.3.1 Number of subjects for this age range 56
Exclusion criteria
Exclusion criteria: • CCA or GB-CA amendable for surgical resection • Prior radiation therapy, chemoradiation, transarterial chemoembolisation (TACE), Radiofrequency ablation (RFA) or selective intraarterial Radiotherapy (SIRT) within the last 3 months, radiation of symptomatic bone metastasis is allowed • Concomitant photodynamic therapy or intraductal radiofrequency ablation within the last 8 weeks • Child Pugh stage B or C (> 6 points) in patients with cirrhosis (Appendix 21.3) • Massive, uncontrolled ascites • Systemic anticancer chemotherapy other than Gemcitabin and a platin derivate (Cisplatin, Carboplatin or Oxaliplatin) • Cardiac disease: congestive heart failure > class II NYHA • Known uncontrolled brain metastasis • History of bone marrow or organ allograft • Active clinically serious infections > CTCAE grade 2 beside of chronic hepatitis C virus infection • Major surgery within 4 weeks of first dose of study drug, port implantation is allowed • Known or suspected allergies to 5-FU, folinic acid or irinotecan • Previous cancer that is distinct in primary site or histology from CCA or GB-CA except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry • Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study • Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment • Pregnancy or breast feeding women • Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Determination of the progression free survival (PFS) in FOLFIRI arm > 2 months;Secondary Objective: Determination of •overall survival (OS) •time to progression (TTP) by RECIST 1.1 •overall response rate (either complete response, CR, or partial response, as measured by RECIST 1.1 •safety profile •quality of life (EORTC QLQ-C30 questionnaire) ;Primary end point(s): Determination of the progression free survival (PFS) in FOLFIRI arm > 2 months;Timepoint(s) of evaluation of this end point: every 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - overall survival (OS) - time to progression (TTP) by RECIST 1.1 - overall response rate (either complete response, CR, or partial response, as measured by RECIST 1.1 - safety profile - quality of life (EORTC QLQ-C30 questionnaire) ;Timepoint(s) of evaluation of this end point: - overall survival (OS): every visit - time to progression (TTP) by RECIST 1.1: every 8 weeks - overall response rate (either complete response, CR, or partial response, as measured by RECIST 1.1: every 8 weeks - safety Profile: every visit - quality of life (EORTC QLQ-C30 questionnaire): every 2 weeks | — |
Countries
Germany
Contacts
Public ContactStudienambulanz Prof. Zeuzem
Medizinische Klinik 1, Universitätsklinikum der Goethe-Universität Frankfurt
Outcome results
None listed